Teva's Sterile Injectables Plant Hit with FDA Warning

Teva's sterile injectable manufacturing plant in Gödöllő, Hungary, received a warning letter from the U.S. FDA for deficiencies in its manufacturing operations, data integrity program, and laboratory controls.

The warning letter, sent on October 14, followed the FDA's 8-day inspection of the plant in January 2016. Following that inspection, the facility ceased producing all but two of the 200 drugs manufactured at the site. In late May 2016, the FDA issued an import alert, banning the plant from shipping all but the two drugs, Amikacin sulfate and bleomycin, to the United States.

The 15,000-square-meter facility was opened in 2012 and primarily focuses on injectable cancer drugs.

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